Diagnostic of Various Ototoxicity Induced by Cancer Treatment

NCT06490029 | Recruiting

• 1 other identifier: 2023RC04
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex/gender, age, medical condition (cancer patients treated with surgery alone and/or radiotherapy and/or chemotherapy, and healthy volunteers). The main question it aims to answer is:
• To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures. Participants will be studied: Either only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition) Participants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)

Conditions

Ototoxicity, Drug-Induced

Outcome Measures

Primary Outcomes (3)

• Descriptive statistics for audiometry of the various groups

  Percentage of correct consonant identification as a function of signal-to-noise ratio for speech audiometry in noise

  Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)

• Descriptive statistics for electrophysiological tests of the various groups

  amplitudes of the acoustic distortion products collected during the measurement of induced acoustic otoemissions

  Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)

• Descriptive statistics for protein analyses of the various groups

  Concentration of selected proteins in plasma (/mL)

  Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)

Study Arms (23)

A:Previously exposed to CISPLATIN with significant ATL damage

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to CISPLATIN without significant ATL damage

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to cochlear RADIOTHERAPY with significant ATL damage

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to cochlear RADIOTHERAPY WITHOUT significant ATL damage

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN with significant ATL damage

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN WITHOUT significant ATL damage

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to OXALIPLATIN

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to CARBOPLATIN

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to TAXANES

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to VINCALCALOIDS

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Previously exposed to other neurotoxicant

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

B:Patients cured of cancer without ototoxic or neurotoxic exposure

Groupe B

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

B:Companions without ototoxic or neurotoxic exposure

Groupe B

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Hyperacusic patients following cancer treatment

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Tinnitus patients following cancer treatment

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

A:Patients with vestibular disorders following cancer treatment

Groupe A

Diagnostic Test: Auditory, vestibular and electrophysiological investigations

C:Patients with an indication for CISPLATIN recruited prior to any treatment

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

C:Patients indicated for cochlear radiotherapy and recruited prior to treatmen

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

C:Patients with indication for CISPLATIN and cochlear radiotherapy recruited prior any treatment

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

C:Patients with an indication for OXALIPLATIN treatment recruited prior to any treatment

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

C:Patients with indication for CARBOPLATIN recruited prior to any treatment

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

C:Patients with indication for TAXANES therapy recruited prior to any treatment

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

C:Patients with indication for VINCALCALOIDES or other neurotoxicant

Groupe C

Diagnostic Test: Auditory, vestibular and electrophysiological investigations; Diagnostic Test: Biologic investigations; seric proteins

Interventions

Auditory, vestibular and electrophysiological investigations DIAGNOSTIC_TEST

otoacoustic emissions, electrocochleography, vocal audiometry in noise and high-frequency tonal audiometry, impedancemetry

A:Hyperacusic patients following cancer treatment; A:Patients with vestibular disorders following cancer treatment; A:Previously exposed to CARBOPLATIN; A:Previously exposed to CISPLATIN with significant ATL damage; A:Previously exposed to CISPLATIN without significant ATL damage; A:Previously exposed to OXALIPLATIN; A:Previously exposed to TAXANES; A:Previously exposed to VINCALCALOIDS; A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN WITHOUT significant ATL damage; A:Previously exposed to cochlear RADIOTHERAPY & CISPLATIN with significant ATL damage; A:Previously exposed to cochlear RADIOTHERAPY WITHOUT significant ATL damage; A:Previously exposed to cochlear RADIOTHERAPY with significant ATL damage; A:Previously exposed to other neurotoxicant; A:Tinnitus patients following cancer treatment; B:Companions without ototoxic or neurotoxic exposure; B:Patients cured of cancer without ototoxic or neurotoxic exposure; C:Patients indicated for cochlear radiotherapy and recruited prior to treatmen; C:Patients with an indication for CISPLATIN recruited prior to any treatment; C:Patients with an indication for OXALIPLATIN treatment recruited prior to any treatment; C:Patients with indication for CARBOPLATIN recruited prior to any treatment; C:Patients with indication for CISPLATIN and cochlear radiotherapy recruited prior any treatment; C:Patients with indication for TAXANES therapy recruited prior to any treatment; C:Patients with indication for VINCALCALOIDES or other neurotoxicant

Biologic investigations; seric proteins DIAGNOSTIC_TEST

seric proteins

C:Patients indicated for cochlear radiotherapy and recruited prior to treatmen; C:Patients with an indication for CISPLATIN recruited prior to any treatment; C:Patients with an indication for OXALIPLATIN treatment recruited prior to any treatment; C:Patients with indication for CARBOPLATIN recruited prior to any treatment; C:Patients with indication for CISPLATIN and cochlear radiotherapy recruited prior any treatment; C:Patients with indication for TAXANES therapy recruited prior to any treatment; C:Patients with indication for VINCALCALOIDES or other neurotoxicant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated, not treated or to be treated for cancer or hematologic recquiring neurotoxic treatment

You may qualify if:

• Age 18 and over
• Registered with social security
• Signed consents
• Absence of presbycusis prior to cancer treatment (groups A and C)
• No known presbycusis (group B)
• Previous exposure to an ototoxic/neurotoxic agent (group A)
• Indication for initiation of ototoxic/neurotoxic therapy (group C)

You may not qualify if:

• \- Subjects deprived of liberty
• Subjects unable to read or write the French language
• Pregnant and breast-feeding women
• Previous treatment for ototoxicity
• History of bilateral auditory pathology, in particular otosclerosis, perilymphatic fistula, ruptured tympanic membrane, autoimmune hearing loss, acoustic neuroma.
• History of severe head trauma (Glasgow Coma Score \<= 8)
• Abnormal otoscopy or tympanometry In addition for group B
• Previous chemotherapy
• Previous ENT radiotherapy
• Ongoing ototoxic drug therapy (quinine, diuretics, aminoglycosides, aspirin, NSAIDs) or corticosteroid therapy

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

HIA Bégin

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

proteins

MeSH Terms

Conditions

Ototoxicity

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• François Régis FERRAND

  IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex

  STUDY CHAIR

Central Study Contacts

François-Régis FERRAND

CONTACT

0178651249; francois-regis.ferrand@def.gouv.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 39 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 8, 2024
• Study Start: June 19, 2024
• Primary Completion: March 19, 2025
• Study Completion (Estimated): September 19, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

FR (1)